FDA Looks To Congress

Since Congress passed the 2018 farm bill, the FDA has allowed sales of the products that are manufactured and marketed in compliance with its regulations while still deeming the ingredients unlawful.

The FDA opened a docket in April 2019 on considering a pathway that could be adopted through a rulemaking process that would make cannabinoids lawful as dietary ingredients under its regulatory framework for manufacturing and marketing dietary supplements established by the Dietary Supplement and Health Education Act, Public Law 103-417.

The docket was re-opened more than once before the FDA opened it indefinitely because little information was being submitted on the agency’s primary question, safety of hemp-derived cannabinoids used as ingredients in non-drug products. (Also see "FDA ISO Data On CBD Safety In Supplements, Sees Potential As Well As Risks " - HBW Insight, 20 November, 2019.)

As well, multiple agency officials have said that a change in its policy for the ingredients could be more quickly established by Congress than by rulemaking. (Also see "Lawful Use Of Cannabidiols In Supplements ‘Different Than The Rest’ Of US FDA Regulations?" - HBW Insight, 7 October, 2020.)

“Since FDA seems to be slow doing something like that, we will continue to ask Congress to do it directly,” said David Spangler, the Consumer Healthcare Products Association’s senior vice president for legal, government and regulatory affairs.

Legislating Hemp As Dietary Ingredient: Wrapping US Market In A Bow, Or Tying DSHEA In Knots?

More from Cannabis/CBD

More from Ingredients & Safety